Decision-support system controls insulin levels for critically ill
19 March 2008
Large numbers of unnecessary deaths and avoidable medical
complications in intensive care units (ICU) are attributable to the
difficulties of treating high glucose levels in critically ill patients’
blood. That is about to change for the better thanks to a new automated
insulin delivery system developed by European researchers.
A common side effect of stress and trauma in critically ill patients
is a rapid increase in blood glucose levels. As with diabetes, the
levels can be reduced and controlled by the infusion of insulin. But
glucose levels peak and change much more quickly in the ICU environment
and there is little room for trial and error. If the situation is not
normalised, then complications and even deaths can and do occur.
Twice in the past, Europe-wide studies and trials were put in place
to try and come up with a solution to the problem. But in both cases
they were prematurely halted because researchers could not solve the
problem of overcompensating and patients developing hypoglycaemia, or
abnormally low blood sugar levels.
“What these studies did clearly indicate is that the establishment of
normal glucose levels in critically ill patients is very difficult to
achieve without some sort of automated system to help the nurses,” says
Dr Martin Ellmerer, scientific coordinator of the CLINICIP project which
has developed just such a system.
Nurses’ no-nonsense approach CLINICIP started by surveying ICUs in a
number of European hospitals and interviewing nursing staff. “We found
that ICU staff did not want to see additional catheters in patients,
they did not want extra equipment taking up space, and costs had to be
kept right down so as not to eat into funds for other vital equipment,”
says Ellmerer. “So, right from the start the requirements were really
Partners in this EU-funded project, academic medical institutions
plus one private-sector medical equipment manufacturer, decided they
needed to develop a two-step approach. “We first developed a
decision-support system which met all the criteria outlined by the ICU
staff, and later developed a fully automated system,” he tells ICT
At the heart of both systems is sophisticated computerised
decision-support system written especially for this project.
With the decision-support system, nurses still have to draw blood
from patients in the traditional way and test it for glucose levels.
They enter the information via the touchscreen user interface the
researchers have developed. The decision-support system calculates how
much insulin is needed and automatically administers it. It also alerts
the nurse when a new blood sample needs to be taken and analysed — half
an hour in the worst cases and up to four hours in less severe cases.
“We have fully functioning prototypes of the decision-support system
which we successfully trialled in ICUs at different hospitals around
Europe,” Ellmerer says. The project’s industrial partner, B Braun
Melsungen AG, is ready to go into commercial production of the system
working together with the clinical partners.
“We will first have to go through an approval process and the systems
should be commercially available to hospitals in mid-2009,” Ellmerer
says. B Braun is one of the leading manufacturers of infusion systems
used in hospitals, and the CLINICIP technology will be incorporated into
these as it was during the trials.
At the same time the prototype was being developed and tested,
CLINICIP researchers were working on sensors for a fully automated,
closed-loop control system to both monitor glucose levels and administer
insulin with no involvement from a nurse.
The drawback of this is that a dedicated needle is necessary.
“Unfortunately, this is unavoidable for a fully automated system,”
Ellmerer points out. Using fibre-optic technology the needle draws
blood, sends it for analysis and then returns it to the patient’s vein
as well as administering the necessary dose of insulin.
“We have performed a proof-of-concept study to show we are able to
establish glucose control in a clinical setting,” Ellmerer says.
To develop the sensor technology further and then commercialise it, a
spin-off company will be set up with Ellmerer as CEO and one of the
shareholders. The other shareholders are individuals from project
partners in CLINICIP. The spin-off will work closely with B Braun and
the partners, although they are not stakeholders in it.
Ellmerer expects the fully automated two-step system to be
commercially available in 2011.
“Our research and the products which result from it should have a
pretty fundamental impact on ICUs,” he says. “They should improve
survival chances, reduce complications, such as sepsis and organ
failure, and reduce the time patients need to spend in ICUs.”
Source: ICT Results